Cleared Traditional

K905606 - EXTERNAL FETAL MONITOR TRANSDUCER HOLDER

K905606 is the FDA 510(k) clearance for EXTERNAL FETAL MONITOR TRANSDUCER HOLDER by Atheus Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HGM) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K905606 · Atheus Corp. · Obstetrics & Gynecology device
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Mar 1991
Decision
88d
Days
Class 2
Risk

K905606 is an FDA 510(k) clearance for the EXTERNAL FETAL MONITOR TRANSDUCER HOLDER. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Atheus Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 12, 1991 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Atheus Corp. devices

Submission Details

510(k) Number K905606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1990
Decision Date March 12, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 160d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 67
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K905606.
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
K921957 · Hewlett-Packard Co. · Sep 1993
COROMETRICS MODEL 150 FETAL MONITOR
K920376 · Ge Medical Systems Information Technologies · Apr 1992
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST
K910260 · Ge Medical Systems Information Technologies · Mar 1991
CATALOG NUMBER 2609 LEG PLATE
K905295 · Ge Medical Systems Information Technologies · Feb 1991
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL
K904358 · Ge Medical Systems Information Technologies · Oct 1990
M1350A FETAL MONITOR (INTRAPARTUM)
K900480 · Hewlett-Packard Co. · Jul 1990